Intravesical instillation of analgesic and anticholinergic drugs have shown efficacy in the treatment of pain and voiding symptoms. Unfortunately, drug loss with urination and dilution in the bladder limit their durability and clinical usefulness. We have recently developed and tested In-Vitro, a sustained delivery system (TRG-100) of fixed-dose combination of lidocaine and oxybutynin designed to allow for a longer exposure of the urinary bladder to the drugs. This study assessed the safety and efficacy of TRG-100 in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), overactive bladder (OAB) and endourological intervention stented (EUI) patients in an open-label, prospective study.
Thirty-six patients were enrolled: 10 IC/BPS, 10 OAB and 16 EUI. EUI patients received a once-weekly installation until stent removal, OAB and IC/BPS patient received weekly installations for 4 consecutive weeks. Treatment effect was assessed by visual-analog scale (VAS) score for the EUI group, voiding diaries for OAB group and VAS score, voiding diaries and O'Leary Sant questionnaires (OSQ) for the IC/BPS group.
The EUI group showed a mean 4-point improvement in their VAS score. The OAB group showed 33.54% reduction in frequency of urination and IC/PBS group showed a mean of 3.2-point improvement in their VAS score, 25.43% reduction in frequency of urination and a mean 8.1-point reduction in OSQ score. All changes were statistically significant.
Intravesical instillation of TRG-100 was found to be safe and efficient in reducing pain and irritative bladder symptoms in our study population. TRG-100 efficacy and safety should be further assessed in a large, randomized control trial.
Urology. 2023 May 31 [Epub ahead of print]
Galiya Raisin, David Dothan, Dolev Perez, Natshe Ala-Adin, Ilan Kafka, Ofer Shenfeld, Shira Hatumi, Nadav Malchi, Avi Gordon, Dan Touitou, Robert Moldwin, Taher Nassar, Boris Chertin
Department of Urology, Shaare Zedek Medical Center, Faculty of Medicine Hebrew University, Jerusalem. Electronic address: ., Department of Urology, Shaare Zedek Medical Center, Faculty of Medicine Hebrew University, Jerusalem., Clalit Health Services, Tel Aviv, Israel., Trigone Pharma Ltd2., Raanana, Israel., The Smith Institute for Urology at Northwell Health, Lake Success, New York; Department of Urology, Hofstra North Shore-LIJ School of Medicine, New Hyde Park, New York., The Institute for Drug Research, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, Israel.